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Positive phase 3 trial results for Trimel’s Natesto testosterone nasal gel
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Results of a phase 3 clinical trial of a new testosterone nasal gel called Natesto were presented on Saturday 7th March at the Endocrine Society's 97th annual meeting in San Diego. The gel is manufactured by Trimel Pharmaceuticals and the phase 3 results indicate that it raises low testosterone levels in men to normal, with few side effects. Lead study author Dr Alan Rogol of the University of Virginia and a consultant to Trimel said: "The unique delivery system makes this a convenient and easy-to-use, self-administered form of testosterone to treat adult males with hypogonadism [low testosterone]. Also important is that intranasal testosterone minimizes the risk of unwanted secondary exposure of testosterone to women or children." The latter point is important as there is a risk of transfer to others from testosterone products applied to the skin. Natesto, on the other hand, is designed to be administered in specified amounts by a multiple-dose pump dispenser applied to the nostrils.

Natesto was approved last May by the U.S. Food and Drug Administration. In the phase 3 trial presented at the Endocrine Society meeting, effectiveness and safety of the nasal gel was assessed in 306 men with hypogonadism attending 39 U.S. outpatient centres. Men were randomly assigned to use Natesto for 90 days in both nostrils either twice a day (228 men) or three times a day (78 men) in order to determine the most effective dose. They remained on the drug for another 90 or 180 days for evaluation of both tolerance and effects of treatment.

The results indicated that after 90 days, blood testosterone levels were in the normal range for 90% of the men who applied the gel three times a day as opposed to 71% of the twice-daily users. This informed the decision of Trimel to recommend dosing of three times a day in each nostril, to achieve a total daily dose of 33 mg. No serious adverse effects were noted in either dosing group and rates of problems of tolerance of the gel were low, with 3.7% of the thrice-daily users discontinuing the drug due to side-effects. Treatment results in significantly improved erectile function and mood. 84% of the 99 men who completed a survey on their experience with the drug, reported feeling confident that they were correctly using the applicator within two days of beginning treatment. Dr Rogol concluded: "These results indicate that testosterone nasal gel is an effective and practical alternative to other available testosterone replacement therapy products."

Reference: Rogol A. A Novel Testosterone Nasal Gel Formulation Normalizes Androgen Levels in Hypogonadal Men. Presented March 7 2013, The Endocrine Society's 97th Annual Meeting (San Diego).

Press release available at: http://www.eurekalert.org/pub_releases/2015-03/tes-tng030615.php
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